Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00984529

Purpose

The purpose of this study is to determine whether treatment with candesartan cilexetil for at least 6 months in patients with chronic heart failure improves clinical signs and symptoms of chronic heart failure.

Condition
Chronic Heart Failure

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	Evaluation of Clinical Signs and Symptoms of Chronic Heart Failure in Patients Treated With Candesartan Cilexetil in Croatia

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To evaluate clinical signs and symptoms of chronic heart failure (in terms of NYHA status, fluid retention and tiredness/fatigue) after at least 6 months of treatment with candesartan cilexetil [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate ventricular function after at least 6 months of treatment with candesartan cilexetil [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
To gain insight into usage of candesartan cilexetil in real life for chronic heart failure in Croatia [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]
To evaluate patient`s compliance with prescribed treatment [ Time Frame: 1 visit (after at least 6 months of treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	September 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Cardiologist´s office patients

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Primary Care

Criteria

Inclusion Criteria:

Patients with diagnosed chronic heart failure
Patients treated for at least 6 months with candesartan cilexetil
Signed Informed consent

Exclusion Criteria:

Hypersensitivity to candesartan cilexetil
Pregnancy / lactation
Severe hepatic impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984529

Locations

Croatia
Research Site
Biograd, Croatia
Research Site
Bjelovar, Croatia
Reserach Site
Cakovec, Croatia
Research Site
Karlovac, Croatia
Reserach Site
Krapinske Toplice, Croatia
Research Site
Novi Marof, Croatia
Research Site
Opatija, Croatia
Research Site
Osijek, Croatia
Research Site
Pula, Croatia
Research Site
Rijeka, Croatia
Reserach Site
Sl. Brod, Croatia
Research Site
Split, Croatia
Research Site
Stubicke Toplice, Croatia
Reserach Site
Zabok, Croatia
Research Site
Zagreb, Croatia

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	MCMD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00984529 History of Changes
Other Study ID Numbers:	NIS-CHR-ATA-2008/1
Study First Received:	September 24, 2009
Last Updated:	January 6, 2011
Health Authority:	Croatia: Ethics Committee; Croatia: Ministry of Health and Social Care

Keywords provided by AstraZeneca:

Chronic heart failure
candesartan cilexetil
clinical signs
symptoms

Additional relevant MeSH terms:

Heart Failure
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Candesartan cilexetil
Candesartan
Angiotensin II Type 1 Receptor Blockers

Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012